01 1F.I.S. Fabbrica Italiana Sintetici
01 1LORAZEPAM
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-27
Pay. Date : 2014-06-20
DMF Number : 5027
Submission : 1983-05-17
Status : Active
Type : II
20
Fis Fabbrica Italiana Sintetici Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is LORAZEPAM, with a corresponding US DMF Number 5027.
Remarkably, this DMF maintains an Active status since its submission on May 17, 1983, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 27, 2014, and payment made on June 20, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
